A Methadone Maintenance Treatment Outcome Study in Three Provinces in China
This study is currently recruiting participants.
Verified April 2012 by Centers for Disease Control and Prevention
Sponsor:
Collaborator:
National Center for AIDS/STD Control and Prevention, China CDC
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01315054
First received: March 14, 2011
Last updated: April 12, 2012
Last verified: April 2012
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Purpose
Methadone treatment has became one of main actions taken in China to control the spread of HIV among drug users. However，the average methadone dose used is relatively low. An intensive methadone maintenance treatment (MMT) provider training on methadone dosage may be effective in increasing the methadone dose levels prescribed to new patients. The study will evaluate the effectiveness of a tailored education program for MMT service providers using subsequent methadone dose prescribed to new patients. The effects of methadone dose, with and without the inclusion of additional psychosocial services, will then be measured through MMT retention and illicit opioid use.
| Condition | Intervention |
|---|---|
|
HIV Hepatitis C Syphilis Herpes Simplex Type II |
Behavioral: MMT provider dosage training Behavioral: targeted counseling Other: national guidelines |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | A Methadone Maintenance Treatment Outcome Study in Three Provinces in China: Comparative Evaluation of the Impact of an Intensive Health Care Provider Training Program Combined With Expanded Services on Treatment Retention, Heroin Use, Methadone Dosing and HIV Risk Practices |
Resource links provided by NLM:
Further study details as provided by Centers for Disease Control and Prevention:
Primary Outcome Measures:
- MMT retention rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Illicit opioid use rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]by urinalysis and self-report
Secondary Outcome Measures:
- HIV, HCV, syphilis and HSV-2 infection seroconversion rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- High risk needle practice [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- High risk sexual practice [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Quality of life（WHO Quality of Life -BREF） [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- All-cause mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 7700 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control arm
Using currently practiced methadone dosage prescription methods
|
Other: national guidelines
Provided a hard copy of the existing national guidelines for methadone dosing
Other Name: dosing guidelines
|
|
Experimental: MMT provider dosage training
Intensive health care provider training on prescribing methadone dosage based on national guidelines
|
Behavioral: MMT provider dosage training
Training on methadone dosing provided to health care providers working in methadone maintenance clinics
Other Name: training
Other: national guidelines
Provided a hard copy of the existing national guidelines for methadone dosing
Other Name: dosing guidelines
|
|
Experimental: MMT provider dosage training/counseling
Intensive health care provider training on prescribing methadone dosage, plus providing on-site psychosocial counseling services and peer support to clients .
|
Behavioral: MMT provider dosage training
Training on methadone dosing provided to health care providers working in methadone maintenance clinics
Other Name: training
Behavioral: targeted counseling
targeted counseling provided to methadone maintenance clinic attendees
Other Name: counseling
Other: national guidelines
Provided a hard copy of the existing national guidelines for methadone dosing
Other Name: dosing guidelines
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- client participants will include both men and women who are opiate-dependent drug users who started MMT not more than one month prior to enrollment in the study
- 18 years of age or older
- residing in the study areas
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315054
Contacts
| Contact: Marc Bulterys, PhD | 86-10-65329901 ext 222 | zbe2@cdc.gov |
| Contact: Li Zhijun | 86-10-65329901 | lzj@cn.cdc.gov |
Locations
| China | |
| National Center for HIV/STD Prevention and Control, China CDC | Recruiting |
| Beijing, China, 100050 | |
| Principal Investigator: Wu Zunyou, PhD | |
| Principal Investigator: Marc bulterys, PhD | |
| Principal Investigator: Li Zhijun | |
Sponsors and Collaborators
National Center for AIDS/STD Control and Prevention, China CDC
Investigators
| Principal Investigator: | Marc Bulterys, MD, PhD | US CDC GAP China |
More Information
No publications provided
| Responsible Party: | Centers for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT01315054 History of Changes |
| Other Study ID Numbers: | CDC-6014.0, CN_09_217 |
| Study First Received: | March 14, 2011 |
| Last Updated: | April 12, 2012 |
| Health Authority: | China: Institutional Review Board United States: Federal Government |
Keywords provided by Centers for Disease Control and Prevention:
|
IDUs high risk behaviors HIV MMT dosage and retention psychosocial services |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Herpes Simplex Syphilis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Herpesviridae Infections DNA Virus Infections |
Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases Treponemal Infections Gram-Negative Bacterial Infections Bacterial Infections Sexually Transmitted Diseases, Bacterial Spirochaetales Infections Sexually Transmitted Diseases Infection Genital Diseases, Male Genital Diseases, Female Methadone Analgesics, Opioid Analgesics |
ClinicalTrials.gov processed this record on March 03, 2013
